Check Your Hypertension Medication! One Batch Fails Test, 87,000 Tablets Urgently Recalled by Health Authorities

Hypertension patients should carefully check their medication. The Taiwan Food and Drug Administration (TFDA) has announced a new drug recall: 'Beniel F.C. Tablets 8 mg,' a hypertension medication manufactured by Jianqiao Xinyuan Pharmaceutical Biotechnology Co., Ltd., has been found to have dissolution test results below specifications during stability testing, potentially affecting product quality and efficacy stability. An emergency recall has been initiated, covering one batch totaling 87,360 tablets.

Hypertension Drug 'Beniel F.C. Tablets' Found Non-Compliant—Efficacy Concerns Prompt Urgent Recall of 87,000 Tablets

Liu Chia-Ping, Senior Technical Specialist of the Pharmaceutical Division at TFDA, stated that the agency received notification from Jianqiao Xinyuan, the marketing authorization holder, that dissolution test results for the subject drug failed to meet specifications during stability testing. To ensure patient safety, the manufacturer has been ordered to complete the recall by August 24 and submit an investigation report along with preventive and corrective actions.

Dissolution Test Below Specification: Summary of Affected Batch and Drug Information

- Product Name: Beniel F.C. Tablets 8 mg - License Number: TFDA Drug Manufacturing License No. 057368 - Active Ingredient: benidipine hydrochloride - Approved Indication: Hypertension - Affected Batch Number: 2KA31 - Quantity Sold: 87,360 tablets - Recall Deadline: August 24, 2025

If the manufacturer fails to complete the recall within the specified timeframe, the TFDA will impose a fine of between NTD 200,000 and NTD 5,000,000 under Article 91 of the Pharmaceutical Affairs Act.

Will There Be a Drug Shortage? TFDA: Sufficient Stock, No Supply Concerns

Regarding patient concerns about potential drug shortages, the TFDA confirmed with the manufacturer that other unaffected batches are still available on the market and inventory levels are sufficient. Production lines are also operating continuously. Additionally, there are two other approved medications with the same active ingredient available domestically, so no shortage is anticipated.

How to Check Your Hypertension Medication: Patient Guidelines and Recommended Actions

| Item | Recommended Action | |------|--------------------| | Verify Batch Number | Check if the batch number on your medication bottle or packaging is '2KA31' | | Do Not Stop Medication Abruptly | Hypertension patients who discontinue medication without medical advice risk severe blood pressure spikes | | Consult Your Physician Promptly | If you have concerns about your medication, schedule a visit to discuss alternative prescriptions with your doctor |

Q1: Why does a 'dissolution test below specification' require a drug recall?

A: Dissolution testing evaluates the rate at which a drug releases and is absorbed in the human body. Results below specification indicate that the drug may not release as effectively as intended, potentially reducing efficacy or compromising stability.

Q2: What should patients currently taking this medication do?

A: If your medication batch number is '2KA31,' do not stop taking it abruptly. Instead, promptly consult your physician to evaluate switching to an unaffected batch or an appropriate alternative medication.